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Cited by 262Drug Solubulity and Delivery SystemsNanoparticle-Based Drug DeliveryAdvanced Drug Delivery Systems

A Review of In Vitro Drug Release Test Methods for Nano-Sized Dosage Forms

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D’Souza, Susan·2014·Advances in Pharmaceutics
DOI 10.1155/2014/304757
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Abstract

This review summarizes the methods used to study real-time (37°C) drug release from nanoparticulate drug delivery systems and establish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including sample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel techniques like voltametry and turbidimetry. This review describes the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling. The SS method allows direct measurement of drug release with simple set-up requirements, but sampling is cumbersome. With the CF method, sampling is straightforward but the set-up is time consuming. Set-up as well as sampling is easier with the DM, but it may not be suitable for drugs that bind to the membrane. Novel methods offer the possibility of real-time drug release measurement but may be restricted to certain types of drugs. Of these methods, Level A IVIVCs have been obtained with dialysis, alone or in combination with the sample and separate technique. Future efforts should focus on developing mathematical models that describe drug release mechanisms as well as facilitate formulation development of nano-sized dosage forms.

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  • The most common method used for describing drug release from micelles is dialysis.

    “The most common method used for describing drug release from micelles is the dialysis one.”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [117]

    Section 2.3, “Dialysis Method” (page not provided), calls dialysis the most popular method for assessing drug release from nano-sized dosage forms. It does not establish that dialysis is the most common method specifically for micelles; a search for “micelles” found no passage making that comparison. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • This approach, combined with adequate mathematical models, can be used to predict the actual release kinetic from micelles.

    “This approach, combined with adequate mathematical models, can be used to predict the actual release kinetic from micelles [117,122].”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [117]

    Section 3, “Modeling Drug Release” (page not provided), says mathematical models can describe nanoparticle release profiles and help elucidate release mechanisms. It does not establish that combining the approach with models predicts actual release kinetics specifically from micelles; it also cautions that complex release mechanisms require care. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • Each of the non-compendial drug release methods has limitations, and the method selection is made on a case by case basis.

    “Even if these methods are indicated in the literature as suitable for drug release evaluation, each and every one has limitations, and the method selection is made on a case by case basis [116].”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [116]

  • Non-compendial approaches for drug release from nanocarriers use dialysis membrane, ultracentrifugation, or ultrafiltration to separate released drug from encapsulated drug.

    “For this reason, non-compendial approaches are used, where the separation of the released drug from the encapsulated one is generally done either by using a dialysis membrane or by ultracentrifugation or ultrafiltration.”

    From Polymeric micelles in drug delivery: An insight of the techniques for their characterization and assessment in biorelevant conditions (2021) · cites this paper as [116]

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Cited by

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Authors
D’Souza, S.
Affiliations
Sunovion (United States) (US)
Corresponding author
D’Souza, Susan
ORCID
D’Souza, Susan
Venue
Advances in Pharmaceutics
Publisher
Wiley
Published
2014-11-20
Volume
2014
Pages
1-12
ISSN
  • 2314-775X (ISSN-L)
  • 2356-6841
DOI
10.1155/2014/304757
OpenAlex
W2086725441
Cited by
262
References
2
Citations by year
2026: 11 · 2025: 23 · 2024: 20 · 2023: 16 · 2022: 22 · 2021: 49 · 2020: 40 · 2019: 22 · 2018: 25 · 2017: 20 · 2016: 11 · 2015: 3
FWCI
6.43
Type
journal article
Language
en
Open access
Licence
Locations
Advances in Pharmaceutics (publishedVersion, cc-by)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Drug Solubulity and Delivery Systems
  • Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
Keywords
in vitro drug release, nanoparticle drug delivery, continuous flow method, turbidimetry

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